Aprovel 75mg film-coated tablets

The Summary of Product Characteristics (SPC or SmPC) is a specific document, the wording of which has been agreed with the regulatory authority as part of the medicine approval process. It is required before any medicine is allowed on the market in Europe. It is designed to assist doctors and pharmacists in prescribing and supplying the product.

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 14 April 2020 PIL

Reasons for updating

Change to section 6 - marketing authorisation holder

Updated on 10 December 2019 SmPC

Reasons for updating

Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 10 December 2019 PIL

Reasons for updating

Change to section 6 - marketing authorisation holder

Updated on 14 January 2019 PIL

Reasons for updating

Change to section 2 - driving and using machines

Change to section 4 - possible side effects

Change to section 4 - how to report a side effect

Updated on 14 January 2019 SmPC

Reasons for updating

Change to section 4.7 - Effects on ability to drive and use machines

Change to section 4.8 - Undesirable effects

Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. Based on its

pharmacodynamic properties, irbesartan is unlikely to affect theis ability to drive and use machines. When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Updated on 18 September 2018 PIL

Reasons for updating

Change to section 2 - what you need to know - contraindications

Change to section 2 - what you need to know - warnings and precautions

Change to section 2 - use in children and adolescents

Change to section 2 - interactions with other medicines, food or drink

Change to section 2 - excipient warnings

Change to section 4 - possible side effects

Change to section 4 - how to report a side effect

Updated on 17 September 2018 SmPC

Reasons for updating

Change to section 4.7 - Effects on ability to drive and use machines

Change to section 4.8 - Undesirable effects

Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via the YellowCard Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Section 4.7

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. Based on its

pharmacodynamic properties, irbesartan is unlikely to affect theis ability to drive and use machines. When driving vehicles or operating machines, it should be taken into account that dizziness or weariness may occur during treatment

Updated on 21 December 2016 PIL

Reasons for updating

New PIL for new product

Updated on 21 December 2016 PIL

Reasons for updating

Change to section 4 - possible side effects

Change to section 6 - date of revision

Updated on 14 July 2016 SmPC

Reasons for updating

New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 14 July 2016 SmPC

Reasons for updating

Change to section 4.8 - Undesirable effects

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Blood and lymphatic system disorders

Not known: thrombocytopenia.

Updated on 29 October 2014 PIL

Reasons for updating

Change to warnings or special precautions for use

Updated on 2 October 2014 SmPC

Reasons for updating

Change to section 4.1 - Therapeutic indications

Change to section 4.2 - Posology and method of administration

Change to section 4.3 - Contraindications

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Article 31 on RAS Acting Agents

Updated on 9 July 2014 PIL

Reasons for updating

Change to marketing authorisation holder

Updated on 25 October 2013 SmPC

Reasons for updating

Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type IA-IN Bulk variation to change the name of the MAH form the current one "Sanofi Pharma Bristol-Myers Squibb SNC" to the new one "Sanofi Clir SNC". The current address of the MAH remains unchanged "54, rue La Boetie - 75008 Paris".

Updated on 23 October 2013 PIL

Reasons for updating

Change to marketing authorisation holder

Updated on 14 October 2013 SmPC

Reasons for updating

Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

MAH name change: Sanofi Clir SNC

Updated on 16 August 2013 SmPC

Reasons for updating

Change to section 2 - Qualitative and quantitative composition

Change to section 4.2 - Posology and method of administration

Change to section 4.3 - Contraindications

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.8 - Undesirable effects

Change to Section 4.8 – Undesirable effects - how to report a side effect

Change to section 5.2 - Pharmacokinetic properties

Change to section 6.6 - Special precautions for disposal and other handling

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type IIC Aliskiren contra-indication CCDS v27 (WS 148)

Updated on 10 May 2013 SmPC

Reasons for updating

New individual SPC (was previously included in combined SPC)

Legal category: Product subject to medical prescription which may be renewed (B)